benzalkonium chloride/benzocaine (OTC)

Brand and Other Names:Orajel Single Dose
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

benzalkonium chloride/benzocaine

topical solution (touch-free applicator)

  • 0.13%/5%
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Cold Sores

Orajel Single Dose: Apply single dose topically to cold sore (see administration)

Administration

Orajel Single Dose

  • Clean lip area using only warm water or alcohol of any lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick
  • Follow directions on applicator to allow medication to saturate the tip
  • Gently touch the site of the cold sore with the saturated applicator tip; once the area is numb, rub the site of the cold sore and the surrounding area
  • Rub firmly to allow the treatment to deeply penetrate the skin
  • To treat most cold sores, 1 treatment is typically enough, if symptoms go away and then return, apply another dose for the second cold sore
  • Do not exceed ≥3 applications/day
  • Discard after use

Dosage Forms & Strengths

benzalkonium chloride/benzocaine

topical solution (touch-free applicator)

  • 0.13%/5%
more...

Cold Sores

<2 years: Safety and efficacy not established

Orajel Single Dose (≥2 years): Apply single dose topically to cold sore (see administration)

Administration

Orajel Single Dose

  • Clean lip area using only warm water or alcohol of any lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick
  • Follow directions on applicator to allow medication to saturate the tip
  • Gently touch the site of the cold sore with the saturated applicator tip; once the area is numb, rub the site of the cold sore and the surrounding area
  • Rub firmly to allow the treatment to deeply penetrate the skin
  • To treat most cold sores, 1 treatment is typically enough, if symptoms go away and then return, apply another dose for the second cold sore
  • Do not exceed ≥3 applications/day
  • Discard after use
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Adverse Effects

Frequency Not Defined

Temporary stinging at application site

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Warnings

Contraindications

Hypersensitivity

Cautions

For external use only

Flammable, keep away from fire or flame

Stop and contact dentist or physician is symptoms persist >7 days

Ingredients in toothpaste, soft drinks, and some fruit juices can deactivate active ingredient

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Benzalkonium chloride: Topical antiseptic

Benzocaine: Topical anesthetic; decreases the neuronal membrane's permeability to sodium ions, which inhibits depolarization and subsequently blocks conduction of nerve impulses

Also contains 70% isopropyl alcohol

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